Bristol-Myers Squibb Company

Submission Publishing Process Design & Mgmt

Location
Princeton, NJ, US
Posted
Apr 25, 2018
Ref
R1505854
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

This role will be the subject Matter Expert for all submission publishing processes and global Health Authority (FDA, EU and ROW depending on specific role) requirements. Primarily accountable for overseeing the detailed processes associated with Health Authority regulations, internal BMS processes, ensuring that all new changes to FDA electronic guidance are known, implications assessed and all involved know how to respond to such changes. Primarily accountable for ensuring all other R&D functional changes or systems implementations that engage with Global Dossier Management are well integrated into current processes.

  • Leads implementations or new uses of eCTD backbone to submit to the FDA. Leads efforts to onboard new countries to support the use of eCTD in their countries. Identification of upcoming impacts, understanding business requirements, negotiation of design and process development, roles and responsibilities, timing and budget implications. Lead efforts to prepare for future guidance-related implications to publishing and be sure that our vendor provided information meets their needs.
  • Leads troubleshooting of eCTD submission publishing challenges encountered and provides direction to team and external service providers. Ensure publishing team is coordinated and working in the most simplified manner to produce consistent deliverables.
  • Provide feedback to management related to potential risks, issues and continuous improvement opportunities to ensure BMS' relationship with our providers remains positive and effective.
  • Participates in service provider negotiations for operational improvements and understand contractual obligations. Lead communications with various stakeholders and management and collaborate and determine best next steps. Lead efforts to resolve upstream process breakdowns impacting publishing. Ongoing monitoring and management of key stakeholders is a key part of this role. Assess and partner with non-BMS entities to help support their needs associated with publishing (e.g. IMD and PRA).
  • Demonstrated ability to organize/prioritize tasks. Ability to interact with all levels of the organization in a professional manner. Ability to negotiate to acceptable outcomes and ability to influence others. eCTD publishing expertise, FDA electronic requirements knowledge associated with submission publishing. Experience working with external publishing service providers and understanding contractual language and how that relates to execution of work. Demonstrated ability to facilitate issue resolution and conflict management.


Education/Experience:
  • BA/BS degree in science / technology field
  • 5 years relevant regulatory / submissions experience